BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-SAT VETERINARY SENSOR

    MDR report key: 9439052 · Received December 9, 2019

    Report

    Report Number
    2936999-2019-01004
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    NELLCOR PURITAN BENNETT MEXICO SA
    Product Code
    DQA
    PMA / PMN Number
    K162014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING GONADECTOMY PROCEDURE WITH SPO2 MEASUREMENT, THE SENSOR CAUSED A LOW TEMPERATURE BURN ON AN ANIMAL TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235072 V-SAT VETERINARY SENSOR OXIMETER DQA NELLCOR PURITAN BENNETT MEXICO SA V-SAT 122770084X

    Patients

    Seq Age Sex Outcome Treatment
    1